Reported Mar 26, 2014 · Terminated
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser…
China Daheng Group Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: China Daheng Group Inc. · #A9 Shangdi Xinxilu · Beijing · N/A
Is this the product you have?
- DenlaseDiode
- Laser Therapy System and PenlaseDental Laser Therapy System surgical powered. Surgical powered Laser instruments
- Lot codes and dates
- Denlase and Penlase Dental Laser Systems.
- Amount recalled
- 238
Where it was sold
Why it was recalled
Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers
This product could cause temporary or reversible health problems — stop using it.
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